BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBAR JUMBO GRAY

    MDR report key: 2903427 · Received November 5, 2012

    Report

    Report Number
    2903427
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 30, 2012
    Manufacturer
    NEOTECH PRODUCTS, INC.
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    GRAY NEOBAR SEPARATED FROM ADHESIVE ON RIGHT CHEEK. RN AT BEDSIDE WHEN IT HAPPENED, WITNESSED THE EVENT AND IMMEDIATELY TOOK HOLD OF NEOBAR TO KEEP IN PLACE WHILE CALLING RESPIRATORY THERAPIST FOR HELP IN RE-SECURING. INCREASED SECRETIONS ON PATIENT, PREVIOUS PROBLEMS WITH ADHESION ON THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOBAR JUMBO GRAY DEVICE FIXATION TRACHEAL TUBE CBH NEOTECH PRODUCTS, INC. N716H 22047

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR